The Calbiotech Rubella IgM ELISA Kit is intended for the detection of IgM antibody to Rubella in human serum or plasma.
SUMMARY AND EXPLANATION
Rubella is usually a mild disease with infrequent complication. In unvaccinated populations, rubella is primarily a childhood disease. Where children are well-immunized, adolescent and adult infections become more evident. Rubella is spread by direct contact with nasal or throat secretions of infected individuals.Symptoms may include a rash, slight fever, joint aches, headache, discomfort, runny nose and reddened eyes. The incubation period for rubella is 12-23 days; in most cases, symptoms appear within 16-18 days.If contracted during the first trimester of pregnancy, Rubella infection can lead to congenital rubella syndrome (CRS). Infection of a pregnant woman may result in a miscarriage, stillbirth or the birth of an infant with abnormalities, which may include deafness, cataracts, heart defects, liver and spleen damage and mental retardation. CRS occurs among at least 25 percent of infants born to women who have had rubella during the first trimester of pregnancy. The presence of IgG antibody to rubella virus is indicative of vaccination or previous exposure. In individuals with acute rubella infection, four-fold or greater increase in IgG antibody level is indicative of recent infection. Rubella IgM antibodies are detected by ELISA in 100% of patients between days 11-25 after onset of the exanthem, in 60-80% of individuals at days 15-25 after vaccination and in 90-97% of infants with congenital rubella between 2 weeks and 3 months after birth. Rubella IgM antibody often persists for 20-30 days after acute infection or vaccination.
PRINCIPLE OF THE TEST
Diluted patient serum (serum diluent contains sorbent to remove Rheumatoid Factor and human IgG interference) is added to wells coated with purified antigen. IgM specific antibody, if present, binds to the antigen. All unbound materials are washed away and the enzyme conjugate is added to bind to the antibody-antigen complex, if present. Excess enzyme conjugate is washed off and substrate is added. The plate is incubated to allow the hydrolysis of the substrate by the enzyme. The intensity of the color generated is proportional to the amount of IgM specific antibody in the sample.